Couple-Focused Intervention for Breast Cancer Patients

February 2, 2016 updated by: Fox Chase Cancer Center

Couple-Focused Group Intervention for Women With Early-Stage Breast Cancer

The goal of the proposed study is to evaluate the efficacy of 2 couple-focused interventions developed to reduce the psychological distress on women and their partners during and after the breast cancer experience. The first group, an Enhanced Couple-Focused Group (ECG), incorporates cognitive-behavioral interventions (e.g., relaxation, stress management skills) as well as basic relationship communication and support skills (e.g., expressing support needs constructively). The second group, a Couples' Support Group (SG), is a non-structured group where general topics are discussed. The investigators will evaluate the impact of each group condition on patients' psychological adaptation, social and role functioning, and cancer treatment adherence. The investigators will also evaluate whether patient and partner perceptions of relationship support, relationship intimacy, stress management skills, and intervention group support mediate the groups' effects on each other's psychological adaptation.

The investigators hypothesize that ECG will have stronger positive effects on patient general and cancer-related distress and well-being than SG.

The investigators hypothesize that group support will mediate greater improvements in patient psychological functioning in both groups but that the effects of group support will be significantly stronger in SG than ECG.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

611

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care Health System
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Cooper Health System
      • Voorhees, New Jersey, United States, 08043
        • Virtua Health System
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19001
        • Bryn Mawr Hospital
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient has a primary diagnosis of Stage 0 (Ductal Carcinoma in situ), 1, 2, or 3a breast cancer
  • patient has had breast cancer surgery within the last twelve months
  • patient and partner married or cohabitating
  • patient and partner 18 years of age or older
  • patient and partner speak and read English
  • patient and partner can provide meaningful informed consent
  • patient and partner do not have any chronic physical or cognitive illness that would preclude participation in the group sessions
  • couple lives within 2 hour commuting distance to the center from which they are recruited

Exclusion criteria:

- patient is male

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced Couples Group
Enhanced Couples Group: consists of eight 90-minute sessions, conducted weekly. ECG has a didactic educational content presented by the group leader or practice of specific relationship communication, relationship support, and couple-focused stress management. ECG participants are also given instruction about what types of behaviors are unsupportive and training in how to not behave in an unsupportive manner.
Behavioral: Group Counseling
Group counseling
Experimental: Support Group
Support Group: 8 weekly 90-minute group counseling sessions. Using a standard approach to supportive therapy, the group interventionists will focus on encouraging participants to share their experiences with cancer, express their emotions related to the experience, voice problems they have in coping with the cancer, and offer support and advice to other members of the group. The co-facilitators will facilitate expression of affect and the sharing of the group's common issues related to cancer. Each session has a broad topic for discussion. Topics include communication with health care providers, issues related to occupational life, and coping with medical procedures and treatment. No formal or didactic information will be provided.
Behavioral: Group Counseling
Group counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mental Health Inventory
Time Frame: time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention
time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention
Impact of Events Scale-Revised
Time Frame: baseline, 1 week post-intervention, 6 mos post-intervention, 12 mos post-intervention
baseline, 1 week post-intervention, 6 mos post-intervention, 12 mos post-intervention
Well-being Subscale of the Mental Health Inventory (MHI)
Time Frame: baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention
baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Mental Outcomes Survey (MOS SF-36)
Time Frame: baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention
baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention
Adherence to Chemotherapy
Time Frame: 1 yr follow-up
1 yr follow-up
Adherence to Radiation Therapy
Time Frame: 1 yr follow-up
1 yr follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fox Chase Cancer Center

Collaborators

National Cancer Institute (NCI)
Albert Einstein College of Medicine
Christiana Care Health Services
The Cooper Health System
Abington Memorial Hospital
City University of New York, School of Public Health
Virtua Health

Investigators

  • Principal Investigator: Sharon L Manne, PhD, Fox Chase Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 14, 2009

First Submitted That Met QC Criteria

July 14, 2009

First Posted (Estimate)

July 15, 2009

Study Record Updates

Last Update Posted (Estimate)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA-65727
  • R01CA078084-07 (U.S. NIH Grant/Contract)
  • IRB#07-831 (Other Identifier: Fox Chase Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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